ImmuneOnco Biopharmaceuticals (Shanghai) Inc. received an investigational new drug (IND) approval from the National Medical Products Administration of the People's Republic of China (the "NMPA") for initiating a Phase II clinical trial of IMM2510 in combination with chemotherapy for the first-line treatments of non-small cell lung cancer (NSCLC) or triple-negative breast cancer (TNBC). ABOUT IMM2510: IMM2510, independently developed by the Group, is a bispecific molecule with a mAb- Trap structure targeting vascular endothelial growth factor (VEGF) and programmed cell death ligand 1 (PD-L1). IMM2510 can inhibit angiogenesis, leading to tumor shrinkage, and sensitize tumor cells to immune responses, while activating T cells, NK cells, and macrophages via the blockade of PD-L1/programmed cell death protein 1 (PD-1) interaction and the induction of Fc-mediated antibody-dependent cellular cytotoxicity (ADCC)/antibody-dependent cellular phagocytosis (ADCP) activity.

The preliminary data from the Phase I clinical trial of IMM2510 has demonstrated favorable safety and promising efficacy. Among evaluable patients, partial response was achieved for three dose levels of IMM2510 (3 mg/kg, 10 mg/kg and 20 mg/kg). On September 11, 2023, the enrollment of patients for the Phase I dose-escalation study of IMM2510 has been completed, and the recommended Phase II dose has been determined.

Preclinical efficacy studies have shown that IMM2510 exerted stronger synergistic antitumor activities than the combination of a VEGF blocker and a PD-L1 antibody. The preliminary data from the Phase I dose-escalation study of IMM2510 has demonstrated promising efficacy for treatments of refractory or relapsed lung adenocarcinoma, squamous cell lung cancer and thymic carcinomas. The Company has received an IND approval from the NMPA for a Phase I clinical trial of IMM2510 in combination with IMM27M (ADCC enhanced cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody) for late-stage solid tumors in October 2023.

Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee that it will be able to develop, or ultimately market, IMM2510, successfully. Shareholders and potential investors of the Company are advised to exercise due care when dealing in the shares of the Company.